Surgical Saw Blades
FDA 510(k) K950403 · Transidyne General Corp.
510(k) numberK950403
Submission
- Device name
- Surgical Saw Blades
- Applicant
- Transidyne General Corp.
Spartanburg, SC, US - Received
- January 31, 1995
- Decision date
- February 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GFA – Blade, Saw, General & Plastic Surgery, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GFA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971978 | Graft Harvesting SawbladesGFA · Traditional | Wrightmedicaltechnologyinc | 06/18/1997SE |
| K954483 | Stryker Sagittal Saw AttachmentGFA · Traditional | Stryker Instruments | 01/30/1996SE |
| K955229 | Wright Medical Technology SawbladesGFA · Traditional | Wrightmedicaltechnologyinc | 01/18/1996SE |
| K953012 | Disposable & Reusable Surgical Cutting ToolsGFA · Traditional | Boston Surgical Products, Inc. | 07/12/1995SE |
| K940501 | Re-Sharpenable Saw BladesGFA · Traditional | Adven Medical | 06/28/1994SE |
| K933595 | Bur, Surgical, General & Plastic SurgeryGFA · Traditional | Omega Surgical Instruments, Inc. | 03/16/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 3M Health Care, Sarns | 02/24/1994SE |
| K934603 | Surgical Saw BladesGFA · Traditional | American Medical Specialties, Inc. | 02/22/1994SE |
| K931769 | Snap Oscillating SawGFA · Traditional | Surgiquip, Inc. | 01/27/1994SE |
| K934390 | Oscillating Bone Saw Blade, 6200 SeriesGFA · Traditional | Boehringer Laboratories | 01/26/1994SE |
More from Boehringer Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K961217 | Bodily Fluid Disposal KitFXX · Traditional | 07/25/1996SE |
| K955658 | Laceration TrayFRG · Traditional | 01/25/1996SE |
| K950773 | Prophylaxis PackEGS · Traditional | 03/31/1995SESK |
| K950743 | Oral Procedure PackEGS · Traditional | 03/31/1995SESK |
| K950449 | Surgical BurGFF · Traditional | 03/01/1995SE |
| K924811 | I.V. Start KitLRS · Traditional | 06/17/1993SEKD |
| K924243 | Tracheostomy Care KitJOH · Traditional | 06/16/1993SEKD |
| K922339 | Suture Removal KitMCZ · Traditional | 12/11/1992SESK |
| K922041 | Primary Surgical Dressing TrayFMF · Traditional | 11/06/1992SEKD |
| K897133 | Model 1050 - Umbilical Cord Blood Sampling KitCBT · Traditional | 03/30/1990SE |
Questions and answers
When was Surgical Saw Blades cleared by the FDA?
Surgical Saw Blades (K950403) received a 510(k) decision of Substantially Equivalent on February 21, 1995, 21 days after the submission was received.
What is the product code of K950403?
The FDA product code is GFA – Blade, Saw, General & Plastic Surgery, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4820.